Shoe Insole or Midsole with a Tri-Dome Configuration for Foot Rehabilitation

ABSTRACT

The present invention relates to a device to be integrated into an article of footwear, normally as, but not limited to, a shoe innersole or shoe midsole, to interact with the plantar surface of the wearer&#39;s foot, in the region of the foot&#39;s main first layer intrinsic muscles. The present invention produces benefits to address gait related issues associated with weakened foot structure and faulty gait biomechanics.

TECHNICAL FIELD

The present invention relates to a device to be integrated into an article of footwear, normally as, but not limited to, a shoe innersole or shoe midsole, to interact with the plantar surface of the wearer's foot, in the region of the foot's main first layer intrinsic muscles, and the present invention produces benefits to address gait related issues associated with weakened foot structure and faulty gait biomechanics.

BACKGROUND ART

Patents for foot and gait correcting technologies go back for more than a century and act as evidence that there is a recognized link between a variety of pain and discomfort conditions, and the faulty mechanics of the foot. The collected data, and observations made, which has become the basis for defining what “ideal” foot function is, have been derived from populations whom have traditionally worn footwear. The repeated exposure to the bracing designs and concepts, which have been common place in the foot treatment and footwear industries for the past 100 or so years, has been proposed to have detrimental effects on the foot, and most notably a weakening of the foot's supporting muscles and skeletal structure. Normal, or average, values have been taken from these typically shoe-wearing populations and have been used by those skilled in the art of biomechanics, podiatry and related fields, as setting the definitions for “ideal”. Demographic and medical research indicates that some 85% of the population will at some time in their life develop foot related pain. With such a high rate of failure of the foot being able to attain pain-free functioning, it is easy to see that the word “normal” should be used as opposed to “ideal”, and as such it is therefore normal to expect to have sore feet. It is the position of the inventors that this should not be case. It is the position of the inventors that the atrophying of the foot's intrinsic muscles, prevent ideal foot function and thus contribute to un-warranted strains and stresses within the foot's structure. Such strain and stress can be seen as a contributing factor to foot and gait related pain and discomfort of both chronic and acute varieties. As the foot is simply muscle, bone and connective tissue like the rest of the body it is logical that introducing exercise to these muscles can strengthen and rehabilitate them, allowing them to perform the functions originally intended by nature. In other fields of medicine it has been shown that the introduction of biofeedback and/or proprioceptive based stimuli can be used to initiate neuromuscular responses and muscle contractions. In the view of the inventors this same approach can be introduced effectively in the field of foot health and foot rehabilitation.

Over the past century numerous devices have been proposed to address gait and foot related pathologies and discomfort. These devices have tended to focus on 2 main theories; firstly that the foot should be supported and braced; and secondly that the foot should be comforted through cushioning. On the topic of the first theory the disclosure of Ritchey in U.S. Pat. No. 2,660,814 provides for a mechanism wherein the lateral boundaries of the foot are supported under the premise that the lateral and medial arches of the foot should be braced, however the very nature of this device, when inserted into conventional footwear results in a inwardly directed compressive force being exerted on the foot and thus potentially causing compression related pathologies and symptoms on the nerves and soft tissue which reside between the articulations of the foot. This is similar to the device proposed by Schoenhaus et al, in U.S. Pat. No. 5,174,052. In a similar approach the concept of simply supporting the foot's medial, or primary arch, is detailed in inventions and devices such as that of Olson et al in U.S. Pat. No. 2,943,405, Arnoff in U.S. Pat. No. 2,933,835, and Conrad in Canadian Patent 536654, to cite but a few and going back numerous decades.

Insole and foot orthotic inventions focusing on comfort through cushioning have been made in variety of forms and incorporate the use of a variety of materials. Rudy in U.S. Pat. No. 4,183,156 discloses the very popular approach of cushioning through the implementation of an air bladder. This concept has seen many variations through the years starting as far back as Farrimond in U.S. Pat. No. 233,387 (circa 1924). Fluid insoles such as that of Hall in U.S. Pat. No. 4,115,934 have also become very popular. In addition there are numerous products, that have been, or are currently being commercialized, which offer comfort to the foot through cushioning approaches relying on the use of foams, such as the device disclosed by Mattos in U.S. Pat. No. 3,414,988.

In what has been proposed to be a more holistic and ideal approach, Burke, in U.S. Pat. No. 5,404,659, as well as Gardiner, in U.S. Pat. No. 6,301,807 and U.S. Pat. No. 6,732,457, disclose devices proposed to initiate muscle contractions through the introduction of a proprioceptive stimulus to the plantar aspect of the foot. Burke et al in recognizing the inherent short falls of those approaches has further suggested a combination of support and muscle stimulation in their recent USPTO application, US 2011099842(A1).

However in a continued analysis of the foot and gait, and the role of the contributing muscles, it has been found by the inventors, that when using these previously referenced devices of Burke and those of Gardiner there are still considerable shortfalls in promoting the proper rehabilitation of the foot's primary intrinsic musculature, and in association, promoting proper gait.

In regards to the foot there are 4 main layers of foot muscles contributing to the functions of the foot, however the 4^(th) or deepest layer are made up very small muscles and tendons that are associated with muscles located outside of the foot. With respect to the these muscles, when viewed from the top or bottom, these muscles of the foot can be seen to be arranged into three columns or sections with each column running parallel to the long axis of the foot and there being a medial most column, a central column and a lateral most column. Key design features of the present invention are strategically introduced to the plantar aspect with the foot specific to these regions. Although the proprioceptive and biofeedback benefits to be offered by the present invention are likely to cause a main reaction in the muscles of the first layer, the net effect of rehabilitation will not be limited to the first layer and will transcend the other layers to offer benefits to the muscles of the 2^(nd), 3^(rd) and 4^(th) layer also.

The breakdown of the first 3 layers of muscles is as follows:

The key muscles of the first layer, which the present invention primarily interfaces with are:

-   -   Abductor Digiti Minimi, which originates on the lateral process         of the tuberosity of the calcaneus and inserts on the lateral         side of the base of the proximal phalanx of the 5^(th) toe.         Contractions of this muscle spread the 5^(th) toe away from the         fourth toe.     -   Flexor Digitorum Brevis which originates on the medial process         of the calcaneus, the central part of the plantar aponeurosis,         and the intermuscular septa and it inserts into the middle         phalanges of 2nd to 5th toes. The entire muscle belly is firmly         united with the plantar aponeurosis. The contraction of the         Flexor Digitorum Brevis plantar flexes the middle phalanges on         the proximal phalangeal articulation.     -   The Abductor Hallucis which originates on the medial process of         the calcaneus, flexor retinaculum, plantar aponeurosis and         intermuscular septum, and inserts on the plantar half of the         medial side of the base of the proximal phalanx of the great         toe. Contractions of this muscle result in Abduction of the         great toe from the medial line of the foot

More intrinsic to the foot are the muscles of the 2 and 3^(rd) layer which lay deeper within the foot in comparison to the first layer muscles.

The key muscles of the 2^(nd) layer are:

-   -   Quadratus Plantae which has 2 heads that originates on the         medial surface and the lateral border of the inferior surfaces         of the calcaneus and inserts or fuses with the tendon of the         flexor digitorum longus muscle. As it contracts it flexes the         2nd, 3rd, 4th and 5th toes.     -   The Foot Lumbricals which originate from the tendons of the         flexor digitorum and insert onto the medial side of the proximal         phalanx, and into the expansions of the tendons to the extensor         digitorum longus of the 2nd to 5th toes. As they contract they         flex the proximal phalanges on the metatarsals and extend the 2         distal phalanges of the 2nd to 5th toes     -   Also in the second layer are tendons to key muscles which are         located outside of the foot such as the Flexor Hallucis Longus         and the Flexor Digitorum Longus muscles.

Deeper into the foot are the muscles defined collectively as the third layer. The key muscles in this layer are:

-   -   Flexor Digiti Minimi Brevis which originates on the proximal end         of the 5th metatarsal bone and inserts on the lateral side of         the proximal end of the proximal phalanx of the little toe. As         it contracts in results in flexion of the proximal phalanx of         the 5th toe.     -   Adductor Hallucis that has two origin heads; the oblique Head         which originates at the proximal ends of the 2nd, 3rd, and 4th         metatarsals, and the transverse head which originates at the         metatarsophalangeal ligaments of the 3rd, 4th, and 5th toes. The         muscle then inserts on the lateral sesamoid bone of the big toe         and into the proximal phalanx of the big toe. As it contracts it         results in drawing the big toe towards the 2^(nd) toe.     -   Flexor Hallucis Brevis which originates from the medial part of         the under surface of the cuboid bone, from the contiguous         portion of the third cuneiform, and from the prolongation of the         tendon of the Tibialis posterior. The muscle then splits into         two and inserts into the medial and lateral sides of the base of         the first phalanx of the great toe

Figures accompany the patent disclosure to aid in understanding and visualizing the location, positioning and functioning of these muscles.

The earlier inventions disclosed by Burke and those of Gardiner approach the foot from an engineering point of view focusing on the centralized area about which the foot is capable of performing ideal tri-planar functions, and attempt to rehabilitate the foot about this centralized point. However through the anatomical analysis of the muscle locations, and their resulting biomechanical contributions to the stabilization of the foot it is clear that the main supporting musculature located within the foot is under-stimulated by the devices of Burke and those of Gardiner, and thus potentially these devices are ineffective in addressing the main foot muscles responsible for foot stabilization and proper gait.

It is the intent of the present invention to introduce a device capable of primarily promoting a strengthening of the key intrinsic muscles of the first layer of the foot and secondarily an associated strengthening of the muscles of the other three layers. The present invention discloses specific raised areas, engineered to potentially receive removable and replaceable inserts, designed and configured to achieve the desired functions of muscular rehabilitation of the foot's muscles and the simultaneous control of harmful excess pronation during walking, running or other such activities.

BRIEF SUMMARY OF THE INVENTION

The present invention discloses a device designed to interact with the plantar surface of the wearer's foot, most notably in the form of a shoe insole, a shoe midsole, or similar, wherein a shoe is collectively used to define a multitude of foot covering articles including, but not limited to, shoes, boots, sandals, slippers, and socks. The present invention is most distinctively characterized by a dominant or primary area rising upwardly from the body of the device. Said primary area, when viewed from the dorsal aspect is characterized most notably by the presence of three anteriorally directed elongations. Said elongations originate in the rearfoot aligning with the central axis of the calcaneus and marginally distal to the anterior most edge of the calcaneus, and radiate outwardly and anteriorally towards the forefoot. Said primary area, and its three elongations, may be defined when using the dorsal or plantar view of the human foot as a frame of reference, as having a medial most elongation, a central elongation and a lateral most elongation. Said primary area may also be characterized by a defined rearfoot area aligned to the entirety of the calcaneus of the human foot, although this aspect is not essential to the functioning of the present invention it presence allows for rearfoot comfort and customization of the present invention as seen fit by those skilled in the art and as appropriate for the symptoms of patients and consumers. Said primary area, when viewed from the sagittal aspect, can be defined as being an elongated dome or being esker-like, in that there is a noticeable vertically raised area which may take the form of a true apex or of a flatter plateau type surface, and the dome is rather long and slender as opposed to more circular or oval shaped. Herein after said elongations, of the primary area will be referred to taking into account the perimeter shape and domed cross sectional characteristics and as such will be termed the “primary domed elongations” collectively in reference to all three and individually through specifying the lateral most and/or central and/or medial most domed elongation.

The location of the primary domed elongations are positioned such that the highest portion of the elongations, which main take the form of a plateau, ridge or singular apex, are aligned with the muscle bellies of the three main muscles present in the first layer of the plantar musculature and as such the three columns of muscles previously referred to earlier. More specifically the plateau, ridge or apex of the medial most domed elongation is alignable to the muscle belly of the Abductor Hallucis, the plateau, ridge or apex of the central domed elongation is alignable to the muscle belly of the Flexor Digitorium Brevis, and the ridge or apex of the lateral most domed elongation is alignable to the muscle belly of the Abductor Digiti Minimi. Prior inventions and research into muscle physiology and neuromuscular science suggest that the introduction of a strain-stress mechanism to a muscle will create a response in the form of contractions to create an avoidance reaction. These are most noticeably a bio-feedback neuro-physiological function of the Pacinian Corpuscles, Merkel's Discs, Ruffini Cells, Muscle Spindles and the Nociceptors, all of which provide feedback to the brain of the presence of various stimuli including texture, pressure, pain/discomfort and tension. The forced introduction of any extrinsic strain or stress to the body of any muscle will create any combination of muscular reactions initiated by these bio-feedback components. In the present invention the introduction of the primary domed elongations, to the muscle bellies of the muscles previously described, creates an upwardly directed pressure stimuli to which the respective muscles react through an avoidance contraction. The resulting physiological and morphological changes in the muscles of the first layer will lead a structural organization of the foot and thus also create strains and stresses onto the muscles of the deeper layers thus initiating contractions and avoidances responses in those groups also.

In the present invention the primary domed elongations may be an integrated part of the shoe insole, the shoe midsole, or similar; wherein the device is constructed as one integrated unit. In other forms of the present invention the primary domed elongations may be separate from the shoe insole, shoe midsole, or similar; wherein the primary domed elongations, as one unit, may be detached from the shoe insole or midsole device for the purpose of being replaced by another similar primary domed elongation offering differing levels of stimulation, pressure or the like. This may be achieved by varying the materials of fabrication, the density of said materials, the heights of the domed elongations, etc., or a combination thereof.

In another aspect of the present invention the medial, central, and lateral domed elongations and the domed heel area may each be individually separate from the shoe insole, shoe midsole, or similar; wherein any of the 3 primary domed elongations may be detached individually from the shoe insole or midsole device for the purpose of being replaced by another similar domed elongation, designed to fit and replace the domed elongation having been removed, and offering differing levels of stimulation, pressure or the like. This may be achieved by varying the materials of fabrication, the density of said materials, the heights of the domed elongations, etc., or a combination thereof. The use of the invention in this manner will allow those skilled in the art of foot health, foot mechanics, customized foot wear development or similar, to tailor or customize the present invention to address abnormalities specific to the feet or foot of an individual customer or patient.

In another embodiment of the present invention the primary domed elongations, individually or as a singular unit, may have their surface, which engages the plantar aspect of the foot, equipped with a series of upwardly extending nodules. These nodules are designed, positioned, and made of such materials, as to introduce an additional massaging stimulus to the muscle bellies of the Abductor Hallicus, the Flexor Digitorum Brevis and the Abductor Digiti Minimi muscles. These nodules may stimulate said muscles collectively or individually depending on the incorporation of the nodules being applied to all primary domed elongations or to simply to one or two of the domed elongations.

In another embodiment of the present invention the primary domed elongations, collectively or individually, may have design provisions intended to provide specific biomechanical functions as typically desired by those skilled in the art when addressing the individual gait characteristics or symptoms of the patient or customer. In this aspect of the present invention, the base or bottom most surface, of any of the primary domed elongations may be tilted or have a wedge shaped base when viewed in the frontal plane, and as such may be used by those skilled in the art to provide additional motion control or guidance to the feet of the user for the purpose of further enhancing the user's gait biomechanics. In a similar manner the rearfoot area previously described, if removable, may be designed to accommodate desired motion control or guidance requirements of the user and/or may be designed to provide for accommodations to address symptoms or pathologies specific to the heel region of the user, for example, for those skilled in the art, the rearfoot area may be designed to act as a varus wedge or have a recess to address a heel spur formation, or both.

DESCRIPTION OF THE DRAWINGS

FIG. 01 is a dorsal aspect perspective view of the present invention from the lateral to the medial aspect, illustrating the presence of the 3 primary domed elongations and a raised heel area. Also shown is a sectional view highlighting the three primary domed elongations wherein the present invention is constructed as an integrated one-piece unit.

FIG. 02 is a dorsal aspect perspective view of the present invention from the lateral to the medial aspect, illustrating the presence of the 3 primary domed elongations with a standard heel area typical of insoles, foot orthotics and similar, as currently used in the footwear and footcare industries.

FIG. 03 is a dorsal view of the present invention illustrating the size, shape and periphery boundaries of the present invention relative to the human skeletal foot. (Right foot—dorsal aspect shown). Wherein the perimeter of the present invention is depicted by a dashed and dotted line, the perimeter of the primary domed elongations are defined by a solid line, and a central ridge of each elongation is depicted by a dashed line. Also shown in the heel area is a perimeter for a rearfoot raised area to be located corresponding to the location of the calcaneus of the human foot. Also highlighted, by dotted lines, is a region encompassing the foot's Metatarsal Phalangeal Joint.

FIG. 04 a-b-c are planter aspect views of the present invention relative to the first layer muscles of a right human foot wherein;

-   -   FIG. 04 a shows the location of the ridge of the lateral most         domed elongation in a bold dashed line, relative to the         anatomical location of the Abductor Digiti Minimi muscle belly,         as well as the ridges of the medial and central domed         elongations shown in a finer dashed line, and;     -   FIG. 04 b shows the location of the ridge of the central domed         elongation in a bold dashed line, relative to the anatomical         location of the Flexor Digitorum Brevis muscle belly, as well as         the ridges of the lateral and medial domed elongations shown in         a finer dashed line and:     -   FIG. 04 c shows the location of the ridge of the medial         elongation in a bold dashed line, relative to the anatomical         location of the Abductor Hallucis muscle belly, as well as the         ridges of the central and medial elongations shown in a finer         dashed line.

FIG. 05 a-b-c-d-e are plantar aspect views of the present invention illustrating 4 various perimeter shapes of the primary domed area adapted to address symptoms or inefficiencies relating to the foot and/or the gait of the user, wherein;

-   -   FIG. 05 a presents a standard perimeter shape aligned and         positioned such that the interfacing of the primary domed         elongations of the present invention engage with the muscle         bellies of the Abductor Digiti Minimi, Flexor Digitorum Brevis         and Abductor Hallucis muscles and;     -   FIG. 05 b presents a modified perimeter shape aligned and         positioned such that the interfacing of the primary domed         elongations of the present invention engage with the muscle         bellies of the Abductor Digiti Minimi, Flexor Digitorum Brevis         and Abductor Hallucis muscles and the central domed elongation         extends anteriorally, medially and laterally to assist in         supporting the metatarsal arch of the human foot, and;     -   FIG. 05 c presents a modified perimeter shape aligned and         positioned such that the interfacing of the primary domed         elongations of the present invention engage with the muscle         bellies of the Abductor Digiti Minimi, Flexor Digitorum Brevis         and Abductor Hallucis muscles and the central domed elongation         extends medially and laterally to assist in supporting the         metatarsal arch of the human foot and the medial aspect of the         central domed elongation is further extended such that it's         positioning is located plantar to the first metatarsal head for         the purpose of simulating a medial forefoot varus wedge as is         common to those skilled in the art, and;     -   FIG. 05 d presents a modified perimeter shape aligned and         positioned such that the interfacing of the primary domed         elongations of the present invention engage with the muscle         bellies of the Abductor Digiti Minimi, Flexor Digitorum Brevis         and Abductor Hallucis muscles and the medial domed elongation         extends anteriorally and laterally such that it's positioning is         located plantar to the first metatarsal head for the purpose of         simulating a medial forefoot varus wedge as is common to those         skilled in the art.     -   FIG. 05 e presents a modified perimeter shape aligned and         positioned such that the interfacing of the primary domed         elongations of the present invention engage with the muscle         bellies of the Abductor Digiti Minimi, Flexor Digitorum Brevis         and Abductor Hallucis muscles and the medial domed elongation         extends anteriorally and laterally such that its overall shape         and positioning is located plantar to the entirety of the first         metatarsal, medial cuneiform and navicular for the purpose of         simulating a medial arch support as is common to those skilled         in the art.

FIG. 06 is a dorsal aspect perspective view of the present invention from the lateral to the medial aspect illustrating the present invention such that the central domed elongation assists in supporting the metatarsal arch of the human foot as described in above 5 b.

FIG. 07 is a dorsal aspect perspective view of the present invention from the lateral to the medial aspect illustrating the present invention such that the central domed elongation assists in supporting the metatarsal arch of the human foot as described in above 5 b and the medial most elongation is configuration as described in above 5 d to function as a medial forefoot varus wedge.

FIG. 08 is a plantar aspect view of the present invention relative to the first layer muscles of a right human foot in addition estimated cross sections are shown to indicate the general dome like shapes and ridges present in the domed elongations of the present invention, and the estimated cross sectional configuration of the raised heel area. The estimated cross sections shown relate to the construction of the present invention as a one piece unit.

FIG. 09 is a dorsal aspect perspective view of the present invention from the lateral to the medial aspect illustrating the primary domed area such it may take the form of a removable component intended to interface with, and lock into openings in the insole, when introduced in a top-down manner. Also provided are estimated cross sections of the domed elongations showing a possible shape configuration to ensure that the removable primary domed area is securely fastened into position.

FIG. 10 is a dorsal aspect perspective view of the present invention from the lateral to the medial aspect illustrating the primary domed area such it may take the form of a removable component intended to interface with, and lock into openings in the insole when introduced in a bottom-up manner. Also provided are estimated cross sections of the domed elongations showing a possible shape configuration to ensure that said primary domed area is securely fastened into position.

FIG. 11 is a dorsal aspect perspective view of the present invention from the lateral to the medial aspect illustrating the primary domes area such each of the primary features; being the raised heel, the medial, central and lateral domed elongations, may take the form of individual removable components intended to interface with, and lock into openings in the insole, when introduced in a top-down manner.

FIG. 12 is a plantar aspect perspective view of the present invention from the medial to the lateral aspect illustrating the primary domed area such it may take the form of individual removable components intended to be introduced into cavities located on the plantar surface of the present invention and said cavities are positioned to align with each of the primary features; being the raised heel, the medial, central and lateral domed elongations. Also provided are estimated cross sections of the domed elongations showing the alignment of the individual removable components with the respective cavities and domes. Also shown are possible geometries wherein the removable components may sit flat within the respective cavity and the shoe's interior, or may be curved to provide a cantilever spring effect during the compression and rebound which occurs during normal human gait.

FIG. 13 is a plantar aspect perspective view of the present invention from the medial to the lateral aspect illustrating an insert to be applied to the primary dome area such it may take the form of a single removable component intended to be introduced into a cavity located on the plantar surface of the present invention and said cavity is positioned to align with each of the primary features; being the raised heel, the medial, central and lateral domed elongations. Also provided are estimated cross sections of the elongations showing the alignment of the removable components with the respective cavities and domes. Also shown are possible geometries wherein the removable component may sit flat within the respective cavity and the shoe's interior or may be curved to provide a cantilever spring effect during the compression and rebound which occurs during normal human gait.

FIG. 14 is a dorsal aspect perspective view of the present invention from the medial to the lateral aspect illustrating the primary domed area such it may take the form of a single removable component intended to be introduced into a cavity located on the plantar surface of the present invention and said cavity is positioned to align with each of the primary features; being the raised heel, the medial, central and lateral domed elongations. Also provided are estimated cross sections of the elongations showing the alignment of the removable component with the respective cavities and domes. The insole body is shown to have a multitude of openings aligned with upwardly extending nodules which are integrated into the dorsal surface of the removable component. Also shown is a cross section of the present invention assembled wherein the nodules extend upwardly past the surface layer of the insole for the purpose of providing a massage sensation to the wearer's foot in the region of the domed elongations.

FIG. 15 is a dorsal aspect perspective view of the present invention from the lateral to the medial aspect illustrating the presence of the 3 primary domed elongations and a raised heel area, wherein the 3 primary domed elongations have been modified to have upwardly extending nodules the purpose of providing a massage sensation to the wearers foot in the region of the elongations. Also shown is a sectional view wherein the present invention is constructed as a one piece unit, and the dorsal aspect of the primary domed area illustrates possible nodule placement relative to the perimeter of the primary domed area.

FIG. 16 is a sectional view, through the frontal plane, of the medial domed elongation, however the concept shown is applicable to any of the 3 domed elongations, and the rearfoot domed area, wherein the applicable region is shown to be manufactured and designed such that the domed structure sits horizontally on a support surface, as well and in contrast, is the same domed structure wherein the medial aspect of the domed structure has been elevated relative to the lateral aspect and as such functions as a varus wedge, as used by those skilled in the art.

FIG. 17 is an illustration depicting the Cardinal Planes of reference when referring to the anatomical structures of the foot to assist in understanding the text of this disclosure.

FIG. 18 is an illustration showing the key osseous structures of the foot and landmarks on the human foot to assist in understanding the text of this disclosure.

FIG. 19 is an illustration included to provide more detail in understanding the muscles of the first 3 layers of the foot and the compartmentalization of them as medial, central and lateral columns.

FIG. 20 is a dorsal aspect perspective view of the present invention from the lateral to the medial aspect illustrating the present invention such that the medial domed elongation assists in supporting the medial arch of the human foot as described in above 5 e. A proposed frontal plane cross-section of the present invention through the midfoot is also provided illustrating the 3 domed elongations, their highest points and in particular the cross sectional modification to the medial most domed elongation.

Key features designated in the drawings relating specifically to the present invention:

Part Description 1 Present Invention 2 Primary Domed Area 3 Elongations (3) 4 Calcaneus 5 Medial Elongation Anterior End 6 Central Elongation Anterior End 7 Lateral Elongation Anterior End 8 Rearfoot Area 9 Vertically Raised Area 10 Top Surface 11 Lateral Most Dome Elongation 12 Central Domed Elongation 13 Medial Most Domed Elongation 14 Plateau, Ridge or Apex 15 Adductor Hallucis 16 Flexor Digitorium Brevis 17 Adbductor Digiti Minimi 18 Nodules 19 Metatarsal Phalangeal Joint 20 Metatarsal Provision 21 Metatarsal and Forefoot Varus Wedge Provision 22 Forefoot Varus Wedge Provision 23 Unified Primary Area Removable Insert 24 Insole/Midsole Opening 25 Locking System Provisions 26 Individualized Removable Inserts 27 Rearfoot Area Removable Insert 28 Medial Domed Elongation Removable Insert 29 Central Domed Elongation Removable Insert 30 Lateral Domed Elongation Removable Insert 31 Opening to Receive the Rearfoot Area Removable Insert 32 Opening to Receive Medial Domed Elongation Removable Insert 33 Opening to Receive Central Domed Elongation Removable Insert 34 Opening to Receive Lateral Domed Elongation Removable Insert 35 Cavity to Receive the Rearfoot Area Removable Insert 36 Cavity to Receive Medial Domed Elongation Removable Insert 37 Cavity to Receive Central Domed Elongation Removable Insert 38 Cavity to Receive Lateral Domed Elongation Removable Insert 39 Cavity to Receive Unified Primary Area Removable Insert 40 Opening to Receive Nodules 41 Elongations (3) Equipped with Nodules 42 Medial Wedge 43 Accommodation for Heel Spur 44 Insole or Midsole Body 45 Bottom Surface 46 Medial Arch 47 Lateral Arch 48 3^(rd) ray

DETAILED DESCRIPTION OF THE PRESENT INVENTION

The present invention 1 provides for a device in the form of a shoe insole and/or midsole and/or integrated shoe outsole-midsole-insole unit, capable of providing a catalyst for muscle stimulation, muscle strengthening and muscular adaptation to most notably, but not limited to, the primary muscles of the first layer of the foot. In addition the present invention 1 will be shown to include optional provisions to address the individual comfort and gait biomechanical requirements which would be diagnosed and serviced by one skilled in the art of trades including, but not limited to, orthopaedics, podiatry, chiropody, gait biomechanics, custom footwear manufacture, and footwear design and development, herein after referred to collectively as those skilled in the art.

The present invention may be constructed of materials of a semi-pliable and compressible nature such that it is comfortable to the plantar surface of the foot during weight bearing and walking, running, and sports related activities. The materials of choice may include, but are not limited to, polyurethane and its derivatives, ethyl vinyl acetate and its derivatives, visco-elastic polymers, natural sponge rubbers and its derivatives, and other materials displaying similar characteristics. As such the present invention 1 may be constructed through a number of varying manufacturing means including, but not limited to, compression molding, vacuum forming, and injection molding and pouring. The present invention may also be constructed in a manner wherein removable components may be manufactured from the aforementioned materials and from the aforementioned techniques, or they may take the form of bladders or similar, filled with either gaseous, liquid or semi-liquid substrates, or a combination thereof, or they may be designed and constructed of such materials as to act as mechanical devices such as but not limited to spring devices.

More specifically, and as shown in FIGS. 01 through 04, the present invention 1 has a dorsal top surface 10 upon which the primary domed area 2 extends upwardly for the purpose of engaging the plantar aspect of the wearer's foot. As shown clearly in FIGS. 01 through 03, the primary domed area 2 is most notably characterized by 3 elongations 3 which can be referred to in an anatomical manner as a medial elongation, a central elongation, and a lateral elongation. Each elongation extends upwardly from the surface of the present invention 1 for the purpose of introducing pressure to a specific muscle located superior to the respective elongation. The medial most domed elongation 13 is characterized as a domed structure which radiates upwardly, medially and outwardly from the rearfoot area 8 such that it's alignment, relative to the human foot of the wearer, is alignable with the medial aspect of the foot, or as commonly referred to as the medial arch 46, and more specifically is oriented to run parallel to and inferior to the location of the Adbuctor Hallucis 15 muscle. The central domed elongation 12 is characterized as a domed structure which radiates upwardly and centrally outward from the rearfoot area 8 such that it's alignment, relative to the human foot of the wearer, is alignable with the central region of the foot, or as commonly referred to as the “3^(rd) Ray” 48, and more specifically oriented to run parallel to and inferior to the location of the Flexor Digitorium Brevis 16 muscle. The lateral most domed elongation 11 is characterized as a domed structure which radiates upwardly, laterally and outwardly from the rearfoot area 8 such that it's alignment, relative to the human foot, of the wearer is alignable with the lateral aspect of the foot, or as commonly referred to as the lateral arch 47, and more specifically oriented to run parallel to and inferior to the location of the Adbuctor Digiti Minimi 17 muscle. Each of the 3 elongations 3 has a vertically raised area 9, as shown in FIGS. 01 and 02, and the respective vertically raised area 9 extends in parallel with each of the 3 elongations 3 such that it forms a highest region as a plateau, ridge, or apex 14. From a three-dimensional perspective the present invention can be regarded as possessing a lateral most domed elongation 11, a central domed elongation 12 and a medial most domed elongation 13.

Shown clearly in FIGS. 01 through 03, the medial most domed elongation 13 radiates upwardly, medially and anteriorally, such that it has a vertically raised area 9, which may take the form of a plateau, ridge or apex 14 which aligns with the Abductor Hallucis, and the medial most domed elongation 13 does not extend in anteriorally to a location wherein the medial elongation anterior end 5 of the medial most domed elongation 13 interferes with the flexion of the foot as defined by the Metatarsal Phalangeal Joint 19.

Also shown in FIG. 01 through 03 the central domed elongation 12 radiates upwardly, centrally and anteriorally such that that it has a vertically raised area 9, which may take the form of a plateau, ridge or apex 14, aligning with the Flexor Digitorum Brevis and the central domed elongation 12 does not extend anteriorally to a location wherein the central elongation anterior end 6 of the central domed elongation 12 interferes with the flexion of the foot as defined by the Metatarsal Phalangeal Joint 19.

The lateral most domed elongation 11 shown in FIGS. 01 through 03 radiates upwardly, laterally and anteriorally such that that it has a vertically raised area 9, which may take the form of a plateau, ridge or apex 14, aligning with the Abductor Digiti Minimi and the lateral most domed elongation 11 does not extend in anteriorally to a location wherein the lateral elongation anterior end 7 of the lateral most domed elongation 11 interferes with the flexion of the foot as defined by the Metatarsal Phalangeal Joint 19.

In respect to the maximum height at the plateau, ridge or apex 14 this parameter needs to be a function of the absolute length of the present invention 1 as it will be a characteristic that must be relative to the foot of the wearer. In consideration thereof it is essential that the present invention 1 have tolerances allowing it to comfortably interface with a variety of foot types and body weights, and the combination of the two. As such the vertically raised area 9, more clearly shown in the cross-sectional aspect in FIG. 01, of the medial most domed elongation 13, may extend vertically from the top surface 10 of the invention, such that it has a minimum vertical height within the tolerance equivalent to 1% of the length of the present invention 1, and such that it has a maximum vertical height within the tolerance equivalent to 4% of the length of the present invention 1.

In addition to, and as such, the vertically raised area 9, more clearly shown in the cross-sectional aspect in FIG. 01, of the central domed elongation 12 may extend vertically from the top surface 10 of the invention, such that it has a minimum vertical height within the tolerance equivalent to 1% of the length of the present invention 1, and such that it has a maximum vertical height within the tolerance equivalent to 5% of the length of the present invention 1.

In addition to, and as such, the vertically raised area 9, more clearly shown in the cross-sectional aspect in FIG. 01, of the lateral most domed elongation 11 may extend vertically from the top surface 10 of the invention, such that it has a minimum vertical height within the tolerance equivalent to 0.5% of the length of the present invention 1, and such that it has a maximum vertical height within the tolerance equivalent to 3% of the length of the present invention 1.

Regardless of whether the 3 elongations 3 be designed and manufactured such that the present invention 1 is a singular integrated unit a shown in FIGS. 01, 02 and 15, or said 3 elongations 3 are separate components as shown in FIGS. 09 through 14, the heights of the vertically raised area 9, when measured from the top surface 10 must fall within these tolerances.

In consideration of the fact that users of the present invention 1 will often use a variety of footwear styles with varying degrees of compatibility to a “full length insole” as would be the definition given by those skilled in the art, to the present invention 1. It must be noted that the overall geometric characteristics of the present invention 1 maybe transferable or applied to a “three-quarter length ” or “half length” insole or orthotic, and under such design the dimensions would be based on the imaginary total insole length had the insole been made in a full length version. In this manner the benefits of the present invention 1 may be enjoyed users requiring the use of either a ¾ or ½ insole.

As shown in FIG. 02, the present invention 1 maybe constructed so as to offer support and stimulation solely through the introduction of the 3 elongations 3 and the present invention may be constructed as to not include a rearfoot area 8 provision. The present invention 1 may however have the rearfoot area 8, wherein special design features such as a heel spur accommodation 43 may be incorporated for the purpose of increasing the wearer's comfort level. In either option the rearfoot area 8 maybe designed and used in the present invention 1 in such a manner as to allow it to be incorporated as an integrated part of a unified primary area removable insert 23, as shown in FIG. 09 and FIG. 10, or as a separate rearfoot removable insert 27, as shown in FIGS. 11 and 12.

As shown in FIGS. 05 b, 05 c, 05 d and 05 e as well as FIGS. 06 and 07, the 3 elongations 3 and in particular the central domed elongation 6 and the medial most domed elongation 13 have the geometry and dimensions of their anterior most ends modified to address specific foot pathologies and/or gait inefficiencies.

As shown in FIG. 05 b the central domed elongation 12 has its central elongation anterior end 5 widened in the medial and lateral directions such that it is capable of adding additional support in the form of a metatarsal provision 20 synonymous to a metatarsal arch support by those skilled in the art. In this design application the medial most edge of the metatarsal provision 20 should not extend in the medial direction to such an extent as it becomes located inferior to the head of the 1^(st) metatarsal, the metatarsal provision 20 should not extent in the anterior direction to the extent that it interferes with Metatarsal Phalangeal Joint 19, and the metatarsal provision 20 should not extend in the lateral direction to the extent that it becomes located inferior to the head of the 5^(th) metatarsal.

As shown in FIG. 05 c the central domed elongation 12 has its central elongation anterior end 5 widened in the lateral direction and widened significantly in the medial direction such that it is capable of adding additional support to the metatarsal arch and in addition it may also be designed such that it extends in the medial direction to an extent where it lays directly inferior to the head of the 1^(st) metatarsal and acts to elevate the head of the first metatarsal, and as such the central elongation anterior end 6 serves to act both as a metatarsal arch support and as a forefoot medial varus wedge as used by those skilled in the art. In this design application the medial most edge of the metatarsal and forefoot varus wedge provision 21 should extend in the medial direction to such an extent as it becomes located inferior to the head of the 1^(st) metatarsal, however the metatarsal and forefoot varus wedge provision 21 should not extent in the anterior direction to the extent that it interferes with Metatarsal Phalangeal Joint 19, and the metatarsal and forefoot varus wedge provision 21 should not extend in the lateral direction to the extent that it becomes located inferior to the head of the 5^(th) metatarsal.

As shown in FIG. 05 d the medial most dome elongation 13 has the medial elongation anterior end 5 designed and manufactured such that it forms a forefoot varus wedge provision 22. As such the forefoot varus wedge provision 22 should be constructed in manner known to those skilled in the art wherein the medial most aspect of the forefoot varus wedge provision 22 is dimensioned to be thicker, or sit higher, than the lateral most aspect of the forefoot varus wedge provision 22. FIG. 16 illustrates this concept applicable to both the metatarsal and forefoot varus wedge provision 21 and the forefoot varus wedge provision 22, wherein, as shown here as a cross section of a separate component, the medial domed elongation removable insert 28 is shown in a neutral or no wedge effect orientation, and in an orientation wherein a medial wedge 42 effect has been integrated into the design. Wherein this is applicable to the design and configuration of each of the 3 elongations 3, it is also applicable to the rearfoot area 8 as shown also in FIG. 16, where the rearfoot area removable insert 27 is shown in both a neutral orientations as well as an orientation subjected to a medial wedge 42 effect.

As shown in FIG. 05 e the medial most dome elongation 13 has the medial elongation lateral aspect designed and manufactured such that it shape and positioning is located plantar to the entirety of the first metatarsal, medial cuneiform and navicular for the purpose of simulating a medial arch 46 support as is common to those skilled in the art.

FIGS. 06 and 07 provide a perspective view of these modified dome shaped concepts.

In another aspect of the present invention 1 provisions are introduced to allow those skilled in the art to address individual concerns of patients or customers as well as to introduce the present invention 1 as a progressively increasing mode of therapy for muscular rehabilitation. Shown in FIGS. 09 through 13 are examples of the present invention 1 wherein it is comprised of an insole or midsole body 44 wherein the insole or midsole body 44 may have a single insole/midsole opening 24 for the purpose of receiving a unified primary area removable insert 23. Shown in FIG. 09 and FIG. 10 said insert has been designed with locking system provisions 25 to ensure the securing of the unified primary area removable insert 23 into the insole/midsole opening 24. The removability of the unified primary area removable insert 23 allows those skilled in the art to introduce a variety of unified primary area removable inserts 23 each of which may be an insert designed and manufactured to be part of a progressive rehabilitative therapy and/or each may be an insert of specific material and/or density and/or geometry prescribed by those skilled in the art to address patient and customer specific symptoms and gait inefficiencies. In FIG. 13 this basic concept is shown wherein the unified primary area removable insert 23 is shown to be an insert designed to be affixed with a cavity molded or formed into the body of the insole on either the top surface 10 or the bottom surface 45. The present invention 1, when constructed in this manner, would incorporate fastening and securing strategies such as hook and loop devices, for example Velcro™, or two way tape, or interlocking design strategies, such as tongue and groove flooring, designed and integrated into the body of the insole or midsole 44 and correspondingly designed into the appropriate removable component, be it a singular component as in the unified primary area removable insert 23 or as an individual removable inserts 26.

FIGS. 11 and 12 illustrate the concept of the present invention 1 wherein the 3 elongations 3 are applied to the insole or midsole body 44 as individual removable inserts 26. As such those skilled in the art may introduce variations in materials, height, geometries and densities of the rearfoot area removable insert 27, the medial domed elongation removable insert 28, the central domed elongation removable insert 29, and the lateral domed elongation removable insert 30, for the purpose of addressing comfort, pathology or gait mechanics issues of the user. As shown in FIG. 11 the individual removable inserts 26 maybe be designed to interface with the insole or midsole body 44 by being inserted into openings 31, 32, 33, 34 wherein portions of the removable inserts 26 must be deigned to have a locking system provisions 25 to ensure their security to and removability from the insole or midsole body 44.

As shown in FIG. 12 the individual removable inserts 26 maybe be designed to interface with the insole or midsole body 44 by being inserted into cavities 35, 36, 37, 38 located on the top surface 10 or the bottom surface 45 wherein the removable inserts 26 must be deigned such that they would incorporate fastening and securing strategies such as hook and loop devices, for example Velcro™, or two way tape, or interlocking design strategies, such as tongue and groove flooring, to ensure their security to and removability from the insole or midsole body 44.

In either design configuration the individualized removable inserts 26 may be designed to have an orientation wherein their base lays parallel, or flat, to the main body of the present invention, or their base may have a medial wedge 42 effect as shown in FIG. 16. For those skilled in the art, the inserts, be they either individual or as part of a one piece unit, may also be designed and manufactured such they display orientations characteristic of a valgus wedge device, which simply is the opposite angulation to that of the medial wedge 42.

In another provision of the present invention 1, the primary area 2 and the 3 elongations 3, be they integrated into a unified insole or midsole body 44, or a separate unified primary area removable insert 23, or individualize removable inserts 26, may have on their dorsal aspect, or the surface intended to engage the wearer's foot, a plurality of nodules 18, for the purpose of providing a reflexology or massage sensation to the wearers foot. The application of this concept is shown in FIG. 14 wherein the unified primary area removable insert 23 is shown to have a plurality of nodules 18 which align and are inserted to openings designed to receive said nodules 40 and wherein the nodules are designed in a manner such that they provide the desired properties to allow the security of, and replaceablity of, the insert, be they a separate unified primary area removable insert 23, or individualize removable inserts 26.

This concept is also shown in FIG. 15 wherein the nodules 18 are integrated into the design of the 3 elongations 3 such that they are elongations equipped with nodules 41 in the construction of the present invention as a single unified unit. 

What is claimed is: 1) An insole or midsole or integrated unit sole, for use with an article of footwear, which has a characteristic raised area wherein said raised area sits plantar to the foot and rises upwardly from the invention, to interface with the plantar aspect of the foot, and wherein; said raised area is characterized by the presence of 3 elongated domes running generally parallel to the long axis of the device and wherein the orientation and positioning of the domes creates an arrangement possessing a medial most dome, a central dome and a lateral most dome. 2) An insole or midsole or integrated unit sole, for use with an article of footwear, which has a characteristic raised area wherein said raised area sits plantar to the foot and rises upwardly from the invention, to interface with the plantar aspect of the foot, and wherein; said raised area is characterized by the presence of 3 elongated domes running generally parallel to the long axis of the device and wherein the orientation and positioning of the domes creates an arrangement possessing a medial most dome, a central dome and a lateral most dome and wherein said device has a characteristic upwardly directed dome on raising upward from the surface of the device and is positioned to be aligned with the calcaneus of the human foot. 3) An insole or midsole or integrated unit sole, for use with an article of footwear, which has a characteristic raised area wherein said raised area sits plantar to the foot and rises upwardly from the invention, to interface with the plantar aspect of the foot, and wherein; said raised area is characterized by the presence of 3 elongated domes running generally parallel to the long axis of the device and wherein the orientation and positioning of the domes creates an arrangement possessing a medial most dome, a central dome and a lateral most dome and wherein: said medial dome is specifically positioned to be aligned generally with the medial arch of the human foot, and wherein; said lateral dome is specifically positioned to be aligned generally with the lateral arch of the human foot, and wherein; said central dome is specifically positioned to be aligned and positioned parallel with the 3^(rd) ray of the human foot. 4) A device as disclosed in claim 1 wherein; said medial most dome when measured from the top surface of the device has a minimum height equivalent to 1% of the length of the device and has a maximum height equivalent to 4% of the length of the device, and wherein: said central dome when measured from the top surface of the device has a minimum height equivalent to 1% of the length of the device and has a maximum height equivalent to 5% of the length of the device, and wherein: said lateral dome when measured from the top surface of the device has a minimum height equivalent to 0.5% of the length of the device and has a maximum height equivalent to 3% of the length of the device, and wherein: 5) A device as disclosed in claim 2 wherein; said medial most dome when measured from the top surface of the device has a minimum height equivalent to 1% of the length of the device and has a maximum height equivalent to 4% of the length of the device, and wherein: said central dome when measured from the top surface of the device has a minimum height equivalent to 1% of the length of the device and has a maximum height equivalent to 5% of the length of the device, and wherein: said lateral dome when measured from the top surface of the device has a minimum height equivalent to 0.5% of the length of the device and has a maximum height equivalent to 3% of the length of the device. 6) A device as disclosed in claim 3 wherein; said medial most dome when measured from the top surface of the device has a minimum height equivalent to 1% of the length of the device and has a maximum height equivalent to 4% of the length of the device, and wherein: said central dome when measured from the top surface of the device has a minimum height equivalent to 1% of the length of the device and has a maximum height equivalent to 5% of the length of the device, and wherein: said lateral dome when measured from the top surface of the device has a minimum height equivalent to 0.5% of the length of the device and has a maximum height equivalent to 3% of the length of the device, and wherein: 7) A device as disclosed in claim 3 wherein; said medial most dome is specifically positioned to be aligned with the Abductor Hallucis Brevis muscle of the user's foot and said medial most dome introduces an upwardly directed pressure onto the Abductor Hallucis Brevis muscle, and wherein; said central dome is specifically positioned to be aligned with the Flexor Digitorum Brevis muscle of the user's foot and wherein; said lateral most dome introduces an upwardly directed pressure onto the Abductor Digiti Minimi muscle. 8) A device as disclosed in claim 7 wherein; said medial most dome when measured from the top surface of the device has a minimum height equivalent to 1% of the length of the device and has a maximum height equivalent to 4% of the length of the device, and wherein: said central dome when measured from the top surface of the device has a minimum height equivalent to 1% of the length of the device and has a maximum height equivalent to 5% of the length of the device, and wherein: said lateral dome when measured from the top surface of the device has a minimum height equivalent to 0.5% of the length of the device and has a maximum height equivalent to 3% of the length of the device, and wherein: 9) A device as disclosed in claim 1 wherein said insole or midsole or integrated unit sole, for use with an article of footwear, which has a characteristic raised area wherein said raised area sits plantar to the foot and rises upwardly from the invention, to interface with the plantar aspect of the foot, and wherein said raised area is designed with openings or cavities to receive inserts corresponding in size and shape to the 3 domes for the purpose of allowing interchange ability. 10) A device as disclosed in claim 2 wherein said insole or midsole or integrated unit sole, for use with an article of footwear, which has a characteristic raised area wherein said raised area sits plantar to the foot and rises upwardly from the invention, to interface with the plantar aspect of the foot, and wherein said raised area is designed with openings or cavities to receive inserts corresponding in size and shape to the 3 domes for the purpose of allowing interchange ability. 11) A device as disclosed in claim 3 wherein said insole or midsole or integrated unit sole, for use with an article of footwear, which has a characteristic raised area wherein said raised area sits plantar to the foot and rises upwardly from the invention, to interface with the plantar aspect of the foot, and wherein said raised area is designed with openings, or cavities, to receive inserts corresponding in size and shape to the domes for the purpose of allowing interchange ability. 12) A device as disclosed in claim 2 and wherein: said device has a characteristic upwardly directed dome on raising upward from the surface of the device and is positioned to be aligned with the calcaneus of the human foot and wherein; said upwardly directed dome may possess depressions, recesses or cavities. 13) A device as disclosed in claim 3 wherein said insole or midsole or integrated unit sole, for use with an article of footwear, which has a characteristic raised area wherein said raised area sits plantar to the foot and rises upwardly from the invention, to interface with the plantar aspect of the foot, and wherein said raised area is designed with cavities or recesses, to receive inserts corresponding in size and shape to the domes for the purpose of allowing interchange ability, and wherein said cavities or recesses may be located on the bottom surface of the device, or wherein said cavities may be located on the top surface of the device. 